RecruitingNot applicableEN originalGastric cancerEarly / localized

Full-time RDI for ESD: Impact on Major Adverse Events and Procedure Time

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

Gastric cancer remains a major global health burden, ranking fifth in incidence worldwide and disproportionately affecting Asia, with China accounting for a significant share of cases and deaths. Early detection and minimally invasive treatment are critical to improving outcomes. Endoscopic submucosal dissection (ESD) is the preferred curative approach for early gastric cancer, enabling precise, en bloc tumor resection while preserving gastric function. However, ESD is technically complex, time-consuming, and associated with risks such as intraoperative and delayed bleeding and perforation. These complications limit its widespread adoption, particularly outside East Asia. Traditional ESD relies on white light imaging (WLI), which offers limited visualization of submucosal vessels and bleeding sources. Red Dichromatic Imaging (RDI) is an emerging image-enhanced endoscopy technology that uses specific narrow-band wavelengths to enhance the contrast of deep blood vessels and active bleeding sites by exploiting hemoglobin's optical absorption characteristics. Preliminary studies indicate that RDI improves bleeding point identification, facilitates hemostasis, and reduces endoscopists' procedural stress. However, prior research applied RDI only intermittently during bleeding events, leaving its potential benefits throughout the entire ESD procedure unexplored. The "full-time RDI" concept proposes continuous use of RDI during all ESD stages-including submucosal injection, mucosal incision, dissection, and wound management-to enhance visualization of high-risk vessels, improve layer differentiation, and potentially reduce adverse events and operation time. Despite promising retrospective data, robust prospective evidence from large randomized controlled trials is lacking. This multicenter, prospective randomized controlled trial aims to evaluate whether full-course RDI reduces major intraoperative and delayed complications and decreases unexpectedly prolonged operation times compared to conventional WLI-guided ESD in early gastric cancer. Secondary endpoints include procedural efficiency, safety across lesion locations, and operator stress. By rigorously assessing full-time RDI's clinical value, this study addresses an urgent unmet need to improve ESD safety and efficiency, potentially broadening its application and enhancing patient outcomes. The innovation lies in integrating continuous advanced imaging throughout ESD, representing a significant advancement in endoscopic oncology and minimally invasive gastric cancer treatment.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek od 18 do 75 lat
  • Diagnostyka wczesnego raka lub polipa żołądka wymagająca zabiegu ESD
  • Wystarczająca liczba płytek krwi (>10×10⁹/L) i hemoglobiny (>8,0 g/L)
  • Wycofanie leków rozrzedzających krew przed zabiegiem zgodnie z wytycznymi
  • Pisemna zgoda na udział w badaniu

✗ Disqualifies

  • Zaplanowany specjalny wariant zabiegu (hybrid ESD)
  • Wieloogniskowe zmiany w żołądku
  • Zaburzenia krzepnięcia krwi wpływające na ryzyko krwawienia
  • Pacjenci na dializie
  • Niemożność czasowego wycofania leków rozrzedzających krew
  • Zmiana zlokalizowana pod błoną śluzową

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
75 Years
Last updated (source)
August 17, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

The First Affiliated Hospital of Air Force Medical University

Xi'an, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/18/2026.

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